If a group health plan or a health insurance issuer offering group or individual health insurance coverage provides coverage to a qualified individual, then such plan or issuer-
For purposes of paragraph (1)(B), subject to subparagraph (B), routine patient costs include all items and services consistent with the coverage provided in the plan (or coverage) that is typically covered for a qualified individual who is not enrolled in a clinical trial.
For purposes of paragraph (1)(B), routine patient costs does not include-
If one or more participating providers is participating in a clinical trial, nothing in paragraph (1) shall be construed as preventing a plan or issuer from requiring that a qualified individual participate in the trial through such a participating provider if the provider will accept the individual as a participant in the trial.
Notwithstanding paragraph (3), paragraph (1) shall apply to a qualified individual participating in an approved clinical trial that is conducted outside the State in which the qualified individual resides.
For purposes of subsection (a), the term "qualified individual" means an individual who is a participant or beneficiary in a health plan or with coverage described in subsection (a)(1) and who meets the following conditions:
This section shall not be construed to require a group health plan, or a health insurance issuer offering group or individual health insurance coverage, to provide benefits for routine patient care services provided outside of the plan's (or coverage's) health care provider network unless out-of-network benefits are otherwise provided under the plan (or coverage).
In this section, the term "approved clinical trial" means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition and is described in any of the following subparagraphs:
The conditions described in this paragraph, for a study or investigation conducted by a Department, are that the study or investigation has been reviewed and approved through a system of peer review that the Secretary determines-
In this section, the term "life-threatening condition" means any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.
Nothing in this section shall be construed to limit a plan's or issuer's coverage with respect to clinical trials.
Notwithstanding any provision of chapter 89 of title 5, this section shall apply to health plans offered under the program under such chapter.
Notwithstanding any other provision of this chapter, nothing in this section shall preempt State laws that require a clinical trials policy for State regulated health insurance plans that is in addition to the policy required under this section..
1 So in original. Probably should be preceded by "A".
42 U.S.C. § 300gg-8
July 1, 1944, ch. 373, title XXVII, §2709, as added Pub. L. 111-148, title X, §10103(c), Mar. 23, 2010, 124 Stat. 892.
CODIFICATIONAnother section 2709 of act July 1, 1944, is classified to sectionof this title.
PRIOR PROVISIONSA prior section 2709 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see sectionof this title.
- The term "Service" means the Public Health Service;